Clinical Trial Finder

Inclusion Criteria:

• - 21 to 65 years old.

• - Confirmed Crohn's disease diagnosis is with mild to moderate Crohn's disease symptoms (sCDAI>220 <450) - Stable doses of medications are screened; thiopurines, natalizumab, vedolizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week) - Willingness and capacity to significantly change diet (arm 1) - Willing and able to comply with specimen collection and other study procedures, and to complete the study.

Exclusion Criteria:

• - Ostomy.

• - Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening.

• - Use of prescribed probiotics within 4 weeks of screening.

• - > 20mg prednisone or equivalent.

• - Recent C.

difficile colitis.

• - Pregnancy.

- Presence of symptomatic or significant structure or history of obstruction in the past 6 months

Crohn's disease is a chronic recurrent inflammatory disorder of the gastrointestinal that results from an inappropriate inflammatory response to an altered gut microbiome (i.e., dysbiosis). Diet is the main driver of microbiome composition. Diet also has been increasingly recognized as a cost-effective strategy to induce remission in pediatric and adult patients with Crohn's disease but diets that can substitute traditional and locally available foods among Puerto Ricans have not been explored. DAIN, a newly created dietary program, incorporates an extensive patient curriculum of recipes and menus adapted to the local availability and food preferences of Puerto Rican patients with Crohn's disease. This study aims to address three questions: whether DAIN a diet adapted to Puerto Rican patients with Crohn's disease, can: 1) induce clinical response and remission; 2) change the inflammatory tone, and 3) revert dysbiosis in Crohn's disease patients. Participants will be randomized 1:1 ratio into two arms:

• - Arm 1 Crohn's disease patients + DAIN (Experimental): this group of patients will participate in ten weeks of DAIN intervention (From week 1 to week 10) - Arm 2 Crohn's disease patients no intervention (Control): this group of patients will not participate in the DAIN dietary intervention and will continue the usual diet.

Participation in the study lasts for 15 weeks with four-time points: week 0 (baseline), week 6, week 10, and week 14. At each time point, all subjects will complete a series of questionnaires to assess overall health, Crohn's disease activity, and dietary compliance. Blood and stool samples will be also collected at home at each time point. Samples will be either shipped or brought to the Research Unit at the Inflammatory Bowel Disease Clinic at the University of Puerto Rico. The primary outcome is clinical response and remission. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, and (iii) dietary compliance.

Arms

Experimental: Arm1: Crohn's disease patients + DAIN

Participants will have 10 weeks of DAIN intervention (From week 1 to week 10)

No Intervention: Arm 2: Crohn's disease patients no intervention

Participants will continue consuming their usual diet, with no intervention

Interventions

Other: - DAIN

Participants in the experimental arm will have access to the newly created DAIN curriculum including menus, recipes, and recorded 'how to' recipes. Participants in the experimental arm will also have once-per-week dietary counseling with DAIN-trained nutritionists and monthly cooking classes with a DAIN-trained chef.